Critically IllNCT05931809
Evaluation of the Perception of Quality of Care of Patients Admitted to a Medical-Surgical ICU
An observational study of Critically Ill, run by Hospital Sao Domingos.
Trial summary
The objective of this prospective observational cohort study is to describe the perception of quality of care of patients or reference companions admitted to a medical-surgical ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Serqual tool
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients admitted to the 53 beds general ICU during the study period. The SERVQUAL scale will be applied with the questionnaire of expectations in the first 24 hours of admission and perception questionnaire within the first 24 hours after discharge.
Who may be able to join
- Patients ≥ 18 years old
- consent form signed by the patient or a family member.
Who cannot join
- Patients unable to respond and who do not have reference companions
- Patients readmitted to the ICU during the study period.
Trial locations and contacts
No sites are listed yet.
About this study
The objective of this prospective observational cohort study is to describe the perception of quality of care of patients or reference companions admitted to a medical-surgical ICU.
Read the detailed description
Background: Quality assessment in health systems is essential for the improvement and development of services. Assessments using the structure, process and outcomes model are the most widespread, however understanding the health system as a business model makes assessment essential. how much the service is able to meet the expectations of the patient and the market.
The Institute for Healthcare Improvement (IHI) highlights three domains (Triple aim) in which health systems must develop. Among them is "Improving the patient experience". One of the 6 domains of quality of care is patient-centeredness. Several funding institutions and scientific authorities have, in recent years, encouraged patient-centered clinical research with the use of outcomes that are also patient-centered.
The perception of the quality of the service provided to the critically ill patient or even is an uncommon outcome in the literature, especially evaluated with an objective and effective tool.
The SERVQUAL tool proposed by Parasuraman et al. It aims to compare the expectations and perceptions of the patient/companion regarding the quality of care provided.
In the literature, data on patient-centered perspectives and demands are scarce.
Purpose: To identify the difference between expectation and perception of care quality during the stay in the general ICU of a tertiary hospital. Objectives: To evaluate the perception of quality of care of patients admitted to a general ICU through the SERVQUAL tool translated and culturally adapted to the portuguese idiom.
Methods: A prospective, observational cohort study involving adult patients admitted to the general ICU (53 beds) of a tertiary hospital from July 1 to September 30, 2023. The SERVQUAL tool questionnaire of expectations will be applied in the first 24 hours after admission to the ICU and the perception questionnaire applied in the first 24 hours after discharge from the unit.
- Conditions
- Critically Ill
- Being tested
- Serqual tool
- Keywords
- Critically ill patients, Servqual tool, Quality of care, Expectations, Perceptions
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serqual toolBehavioural
The SERVQUAL scale will be applied with the questionnaire of expectations in the first 24 hours after admission and perception questionnaire within the first 24 hours after discharge.
What is being measured
The primary outcome is the main question the study is designed to answer.
Servqual tool
The questionnaire consists of 5 domains with 22 questions graded from 1 to 7 according to perceived quality and expected in each sphere of care delivery. Domains are:
- Tangibles. Equipment, physical structure, presentation of professionals and materials.
- Reliability. Ability to resolve problems and resolve them within the deadline, and record without errors.
- Availability and responsiveness. Ability to inform about the therapeutic plan, to execute on time, availability of professionals to help clients and degree of occupation of professionals to meet demands.
- Security / Trust. Ability to inspire security, education of professionals and knowledge of processes by professionals.
- Empathy. To provide individual attention, standard opening hours, sincere interest in resolving demands and ability to meet demands individually.
The result is analyzed with the calculation: Average result of reality - Average result of expectation = Gap of perception of quality of care.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Domingos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Raimundo Araujo de Azevedo, Hospital Sao Domingos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931809
- Sponsor's protocol ID
- HSD 2023 2
- Status last verified
- Jun 2023
- First submitted
- 17 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burstin H, Leatherman S, Goldmann D. The evolution of healthcare quality measurement in the United States. J Intern Med. 2016 Feb;279(2):154-9. doi: 10.1111/joim.12471.
PubMed 26785953Sixma HJ, Kerssens JJ, Campen CV, Peters L. Quality of care from the patients' perspective: from theoretical concept to a new measuring instrument. Health Expect. 1998 Nov;1(2):82-95. doi: 10.1046/j.1369-6513.1998.00004.x.
PubMed 11281863Jonkisz A, Karniej P, Krasowska D. The Servqual Method as an Assessment Tool of the Quality of Medical Services in Selected Asian Countries. Int J Environ Res Public Health. 2022 Jun 26;19(13):7831. doi: 10.3390/ijerph19137831.
PubMed 35805492Malathi A, Jasim KM. Validating the relationship between service quality, patient sensitivity and experience towards medical applications using SERVQUAL. Int J Med Inform. 2022 Dec;168:104883. doi: 10.1016/j.ijmedinf.2022.104883. Epub 2022 Oct 5.
PubMed 36209699Regaira Martinez E, Sola Iriarte M, Goni Viguria R, Del Barrio Linares M, Margall Coscojuela MA, Asiain Erro MC. [Care quality in intensive care evaluated by the patients using a service quality scale (SERVQUAL)]. Enferm Intensiva. 2010 Jan-Mar;21(1):3-10. doi: 10.1016/j.enfi.2009.10.001. Epub 2010 Feb 1. Spanish.
PubMed 20170830Lu SJ, Kao HO, Chang BL, Gong SI, Liu SM, Ku SC, Jerng JS. Identification of quality gaps in healthcare services using the SERVQUAL instrument and importance-performance analysis in medical intensive care: a prospective study at a medical center in Taiwan. BMC Health Serv Res. 2020 Sep 29;20(1):908. doi: 10.1186/s12913-020-05764-8.
PubMed 32993641Fan LH, Gao L, Liu X, Zhao SH, Mu HT, Li Z, Shi L, Wang LL, Jia XL, Ha M, Lou FG. Patients' perceptions of service quality in China: An investigation using the SERVQUAL model. PLoS One. 2017 Dec 22;12(12):e0190123. doi: 10.1371/journal.pone.0190123. eCollection 2017.
PubMed 29272312
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Perception of Quality of Care of Patients Admitted to a Medical-Surgical ICU
- ClinicalTrials.gov ID
- NCT05931809
- Acronym / sponsor ID
- HSD 2023 2
- Conditions
- Critically Ill
- Keywords
- Critically ill patients, Servqual tool, Quality of care, Expectations, Perceptions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Sao DomingosUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this prospective observational cohort study is to describe the perception of quality of care of patients or reference companions admitted to a medical-surgical ICU.
Detailed description
Background: Quality assessment in health systems is essential for the improvement and development of services. Assessments using the structure, process and outcomes model are the most widespread, however understanding the health system as a business model makes assessment essential. how much the service is able to meet the expectations of the patient and the market.
The Institute for Healthcare Improvement (IHI) highlights three domains (Triple aim) in which health systems must develop. Among them is "Improving the patient experience". One of the 6 domains of quality of care is patient-centeredness. Several funding institutions and scientific authorities have, in recent years, encouraged patient-centered clinical research with the use of outcomes that are also patient-centered.
The perception of the quality of the service provided to the critically ill patient or even is an uncommon outcome in the literature, especially evaluated with an objective and effective tool.
The SERVQUAL tool proposed by Parasuraman et al. It aims to compare the expectations and perceptions of the patient/companion regarding the quality of care provided.
In the literature, data on patient-centered perspectives and demands are scarce.
Purpose: To identify the difference between expectation and perception of care quality during the stay in the general ICU of a tertiary hospital. Objectives: To evaluate the perception of quality of care of patients admitted to a general ICU through the SERVQUAL tool translated and culturally adapted to the portuguese idiom.
Methods: A prospective, observational cohort study involving adult patients admitted to the general ICU (53 beds) of a tertiary hospital from July 1 to September 30, 2023. The SERVQUAL tool questionnaire of expectations will be applied in the first 24 hours after admission to the ICU and the perception questionnaire applied in the first 24 hours after discharge from the unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted to the 53 beds general ICU during the study period. The SERVQUAL scale will be applied with the questionnaire of expectations in the first 24 hours of admission and perception questionnaire within the first 24 hours after discharge.
Key inclusion criteria (2 listed)
- Patients ≥ 18 years old
- consent form signed by the patient or a family member.
Key exclusion criteria (2 listed)
- Patients unable to respond and who do not have reference companions
- Patients readmitted to the ICU during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serqual toolThe SERVQUAL scale will be applied with the questionnaire of expectations in the first 24 hours after admission and perception questionnaire within the first 24 hours after discharge. | Behavioural | – |
Primary outcome
Servqual tool
Time frame: 30 days
The questionnaire consists of 5 domains with 22 questions graded from 1 to 7 according to perceived quality and expected in each sphere of care delivery. Domains are: 1. Tangibles. Equipment, physical structure, presentation of professionals and materials. 2. Reliability. Ability to resolve problems and resolve them within the deadline, and record without errors. 3. Availability and responsiveness. Ability to inform about the therapeutic plan, to execute on time, availability of professionals to help clients and degree of occupation of professionals to meet demands. 4. Security / Trust. Ability to inspire security, education of professionals and knowledge of processes by professionals. 5. Empathy. To provide individual attention, standard opening hours, sincere interest in resolving demands and ability to meet demands individually. The result is analyzed with the calculation: Average result of reality - Average result of expectation = Gap of perception of quality of care.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Results publication: PubMed 26785953Burstin H, Leatherman S, Goldmann D. The evolution of healthcare quality measurement in the United States. J Intern Med. 2016 Feb;279(2):154-9. doi: 10.1111/joim.12471.
- Results publication: PubMed 11281863Sixma HJ, Kerssens JJ, Campen CV, Peters L. Quality of care from the patients' perspective: from theoretical concept to a new measuring instrument. Health Expect. 1998 Nov;1(2):82-95. doi: 10.1046/j.1369-6513.1998.00004.x.
- Results publication: PubMed 35805492Jonkisz A, Karniej P, Krasowska D. The Servqual Method as an Assessment Tool of the Quality of Medical Services in Selected Asian Countries. Int J Environ Res Public Health. 2022 Jun 26;19(13):7831. doi: 10.3390/ijerph19137831.
- Results publication: PubMed 36209699Malathi A, Jasim KM. Validating the relationship between service quality, patient sensitivity and experience towards medical applications using SERVQUAL. Int J Med Inform. 2022 Dec;168:104883. doi: 10.1016/j.ijmedinf.2022.104883. Epub 2022 Oct 5.
- Results publication: PubMed 20170830Regaira Martinez E, Sola Iriarte M, Goni Viguria R, Del Barrio Linares M, Margall Coscojuela MA, Asiain Erro MC. [Care quality in intensive care evaluated by the patients using a service quality scale (SERVQUAL)]. Enferm Intensiva. 2010 Jan-Mar;21(1):3-10. doi: 10.1016/j.enfi.2009.10.001. Epub 2010 Feb 1. Spanish.
- Results publication: PubMed 32993641Lu SJ, Kao HO, Chang BL, Gong SI, Liu SM, Ku SC, Jerng JS. Identification of quality gaps in healthcare services using the SERVQUAL instrument and importance-performance analysis in medical intensive care: a prospective study at a medical center in Taiwan. BMC Health Serv Res. 2020 Sep 29;20(1):908. doi: 10.1186/s12913-020-05764-8.
- Results publication: PubMed 29272312Fan LH, Gao L, Liu X, Zhao SH, Mu HT, Li Z, Shi L, Wang LL, Jia XL, Ha M, Lou FG. Patients' perceptions of service quality in China: An investigation using the SERVQUAL model. PLoS One. 2017 Dec 22;12(12):e0190123. doi: 10.1371/journal.pone.0190123. eCollection 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by Hospital Sao Domingos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JOSE AZEVEDO, MD, PhD (+559832168110, jrazevedo47@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Servqual tool (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05931809, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.